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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05508932
Other study ID # 419/2022/Oss/AOUFe
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date July 1, 2032

Study information

Verified date September 2023
Source University Hospital of Ferrara
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study aims to evaluate the clinical, laboratory and instrumental differences that exist between beta-thalassemia patients with atrial fibrillation and those not affected by arrhythmia.


Description:

Observational, retrospective and prospective, single-center study, which involves the collection of clinical, laboratory, electrocardiographic and imaging data of patients with major or intermediate thalassemia who have performed, from 2012 to 2022, or will perform in the next 10 years, a cardiological evaluation at the Cardiology Unit of the University Hospital of Ferrara. Patients will be divided into two groups: thalassemia patients with atrial fibrillation (paroxysmal, persistent or permanent) and thalassemia patients with no history of atrial fibrillation. The objective of the study is to evaluate whether there is a different prevalence of the characteristics analyzed among these patient populations.


Recruitment information / eligibility

Status Recruiting
Enrollment 350
Est. completion date July 1, 2032
Est. primary completion date June 1, 2032
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Transfusion-dependent Beta-thalassemia; 2. Follow-Up at the Cardiology Unit of the University Hospital of Ferrara; 3. Electrocardiogram performed; 4. Echocardiogram performed. Exclusion Criteria: 1. Age <18 years; 2. State Of pregnancy; 3. Inability to give informed consent.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Matteo Bertini Ferrara

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Atrial fibrillation New onset of Atrial Fibrillation documented at ECG 10 years
Secondary Thromboembolism Stroke or peripheral embolization 10 years
Secondary Epicardial adipose tissue Thickness of fat depot in epicardial region Baseline
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